Phase 3
Completed N=100
A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.
Source: ClinicalTrials.gov NCT01988012 ↗Enrolled (actual)
100
Serious AEs
6.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity — 16.5; 34.1 percentage of participants
◆ Published Evidence
Established
37citations · ~5 / year
Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.
Summary
A multi-center, open-label single-arm study to evaluate the efficacy and safety of tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis. Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) was permitted.
Linked Publications (2)
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Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.
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Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity |
16.5; 34.1 | — |
| PRIMARY Change From Baseline in CDAI |
31.89; -18.29 | — |
| PRIMARY Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission and SDAI Low Disease Activity |
19.2; 38.5 | — |
| PRIMARY Change From Baseline in SDAI |
33.73; -21.41 | — |
| PRIMARY Change From Baseline in Disease Activity Score 28-Erythrocyte-Sedimentation Rate (DAS28-ESR) |
4.98; -2.47 | — |
| PRIMARY Percentage of Participants Achieving 20%, 50% and 70% Improvement in American College of Rheumatology (ACR) Response Scores (ACR20, ACR50 and ACR70) |
62.4; 37.6; 20.0 | — |
| PRIMARY Percentage of Participants With Good to Moderate European League Against Rheumatism (EULAR) Response |
96.4 | — |
| PRIMARY Change From Baseline in TJC and SJC |
21.42; -11.91; 10.30; -7.54 | — |
| PRIMARY Change From Baseline in Percentage of Participants on Tocilizumab Monotherapy |
26; 12 | — |
| PRIMARY Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (PGA VAS) |
69.73; -31.22 | — |
| PRIMARY Change From Baseline in Patient Pain VAS |
64.82; -29.11 | — |
| PRIMARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) |
1.55; -0.34 | — |
| PRIMARY Change From Baseline in Patient Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |
23.46; 6.95 | — |
| PRIMARY Total Scores on Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS) |
7.87; 4.94; 8.56; 5.93 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (AESIs) |
70.0; 7.0 | — |
| SECONDARY Percentage of Participants Who Required Dose Modifications or Discontinued Study Due to AEs |
16; 5 | — |
| SECONDARY Immunogenicity: Percentage of Participants With Anti-tocilizumab Antibodies |
1.0; 0; 0; 0 | — |
| SECONDARY Immunogenicity: Tocilizumab Levels |
35.49; 41.63; 39.53; 19.04 | — |
| SECONDARY Immunogenicity: Change From Week 1 in Soluble Interleukin-6 Receptor (sIL-6R) Levels |
38.33; 475.79; 503.67; 382.26; 309.91 | — |
Eligibility Criteria
Inclusion Criteria
- Adults >/= 18 years of age
- Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) American College of Rheumatology (ACR) criteria or European League Against Rheumatism (EULAR)/ACR (2010) criteria
- Previously treated with the following: three non-biologic DMARDs, and not treated with any biologic agent OR one biologic agent (alone or in combination with non-biologic DMARDs), and discontinued that agent for a reason
- Oral corticosteroids ( /= 4 weeks prior to Baseline
- Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential must not be pregnant
Exclusion Criteria
- Presence of serious, uncontrolled, clinically significant medical conditions
- History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal (GI) disease that might predispose to perforation
- Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
- Any infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
- Clinically significant findings on lab tests and/or hepatitis B or C, or human immunodeficiency virus (HIV) screenings
- Active tuberculosis (TB) requiring treatments within the previous 3 years
- Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years
- History of alcohol, drug, or chemical abuse within 1 year prior to Screening
- Neuropathies or other conditions that might interfere with pain evaluation
- Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline
- Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted
- Functional Class IV as defined by the ACR Classification of Functional Status in-Rheumatoid Arthritis
- Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16
- Prior history of current inflammatory joint disease other than RA
- Exposure to tocilizumab (either IV or subcutaneous administration) at any time prior to Baseline
- Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening
- Previous treatment with any cell-depleting therapies, including investigational agents approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation
- Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline
- Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline
Data sourced from ClinicalTrials.gov (NCT01988012) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.